Automation of GMP Validated Processes in Quality Assurance Testing
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Automation of Quality Assurance processes increasing efficiency within GMP guidelines.

Designed for your processes GMP regulated processes are time consuming and require accurate documentation in addition to traceable sample processing. Accordingly Zinsser Analytic designed a solution for GMP regulated tests for quality assurance. Precise Dilution of Diverse Target Stock Solutions Well Defined GMP Documentation Reproducible and Reliable Results Customized Software Interface

HARDWARE DESIGN The design color of hardware was desired by the customer to fit their lab. Piercing tip to pipette through septum and gripper for 50 mL vials Source rack for ten 50 mL stock solution vials Rack for ten 50 mL pre-dilution vials Single tube vortexer A and B Spare ten 50 mL vials as replacement vials if errors appear Wash station for tip Destination rack for fifty 50 mL vials with dilutions 6 mL Precision syringe pump Balance with housing and ioniser

For GMP regulated quality assurance laboratories a precise definition of automated process steps is crucial to assure the validation of the workflow. The dilution process steps are designed to be applicable to various stock solutions: Dilution Process Targets: The variation coefficient for pipetting should range from < 1.5% for stock solution and < 0.5% for dilution solvent. INPUT • Ten stock solutions. With this process a throughput of 160 dilutions in an 8 h working day is achievable with a preparation time of maximum 180 seconds per dilution.

SOFTWARE SOLUTION FOR YOUR SPECIFIC PROCESS Every process step is designed modularly. Therefore a variety of processes, using differing powders, chemicals and solvents, may be completed. The customised sequential arrangement of the process is composed with a specified MS Excel® file or our Worklist-Generator which is then executed with our WinLissy®-software. With the Worklist-Generator you can create individual processes with many adjustable parameters for sub steps. Worklist Generator Drag and drop the needed methods to the desired positions of the worklist. Pipetting Editor For pipetting...

AMERICAS Zinsser NA, Inc. 19145 Parthenia Street Suite C Northridge, CA 91324 USA Tel: +1 818 341 2906 Fax: +1 818 341 2927 info@zinsserna.com HEADQUARTERS Gardner Denver Thomas GmbH Livry-Gargan-Str. 10 82256 Furstenfeldbruck Germany Tel: +49 8141 2280 0 Fax: +49 8141 8892136 thomas.de@gardnerdenver.com Gardner DenverGENERAL CONTACT EMEA Zinsser Analytic GmbH Schwalbacher Str. 62 65760 Eschborn Germany Tel: +49 6196 58693 0 Fax: +49 6196 58693 80 info.zinsser-analytic@gardnerdenver.com Please check out all our brands for your mission-critical flow control technologies: THOMAS by Gardner...